UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________to __________________ Commission File Number: 001-39409 ALLOVIR, INC. (Exact Name of Registrant as Specified in its Charter) Delaware (S ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________to __________________ Commission File Number: 001-39409 ALLOVIR, INC. (Exact Name of Registrant as Specified in its Charter) Delaware (State ...

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) This section presents the unaudited condensed consolidated financial statements for Q1 2023, detailing a **net loss of $41.2 million** and **total assets of $244.0 million** [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheet Highlights (Unaudited) | Balance Sheet Items | March 31, 2023 (in thousands USD) | December 31, 2022 (in thousands USD) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $115,698 | $106,092 | | Short-term investments | $86,872 | $127,703 | | Total current assets | $212,275 | $243,052 | | **Total assets** | **$244,044** | **$277,079** | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $24,959 | $24,338 | | Total liabilities | $50,512 | $52,560 | | Total stockholders' equity | $193,532 | $224,519 | | **Total liabilities and stockholders' equity** | **$244,044** | **$277,079** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Statement of Operations Summary (Unaudited) | Metric | Three Months Ended March 31, 2023 (in thousands USD) | Three Months Ended March 31, 2022 (in thousands USD) | | :--- | :--- | :--- | | Research and development | $30,718 | $29,067 | | General and administrative | $12,513 | $14,126 | | **Loss from operations** | **$(43,231)** | **$(43,193)** | | Interest income | $1,325 | $148 | | **Net loss** | **$(41,183)** | **$(43,863)** | | **Net loss per share — basic and diluted** | **$(0.44)** | **$(0.69)** | [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) - Total stockholders' equity decreased from **$224.5 million** at December 31, 2022, to **$193.5 million** at March 31, 2023, primarily driven by the **net loss of $41.2 million**, partially offset by **$10.0 million** in stock-based compensation[33](index=33&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary (Unaudited) | Cash Flow Activity | Three Months Ended March 31, 2023 (in thousands USD) | Three Months Ended March 31, 2022 (in thousands USD) | | :--- | :--- | :--- | | Net cash used in operating activities | $(32,118) | $(46,476) | | Net cash provided by (used in) investing activities | $41,724 | $(54,979) | | Net increase (decrease) in cash, cash equivalents, and restricted cash | $9,606 | $(101,455) | | Cash, cash equivalents, and restricted cash at end of period | $116,550 | $101,058 | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) - AlloVir is a late clinical-stage cell therapy company, with its lead product, posoleucel, in three ongoing Phase 3 trials expected to report data in 2024, following positive Phase 2 results in February 2023[38](index=38&type=chunk) - The company believes its **$202.6 million** in cash, cash equivalents, and short-term investments as of March 31, 2023, are sufficient to fund planned operations for at least twelve months, addressing going concern considerations[40](index=40&type=chunk)[44](index=44&type=chunk) - The adoption of ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326), on January 1, 2023, did not materially impact the condensed consolidated financial statements[52](index=52&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition and operational results, reporting a **net loss of $41.2 million** for Q1 2023, with **$202.6 million** in cash sufficient for twelve months of operations - The company's lead product, posoleucel, is in three ongoing Phase 3 registrational trials with data readouts expected in 2024, following positive Phase 2 results for BK viremia in kidney transplant patients in February 2023[89](index=89&type=chunk) Comparison of Operating Expenses (in thousands USD) | Expense Category | Three Months Ended March 31, 2023 (in thousands USD) | Three Months Ended March 31, 2022 (in thousands USD) | Change (in thousands USD) | | :--- | :--- | :--- | :--- | | Research and development | $30,718 | $29,067 | $1,651 | | General and administrative | $12,513 | $14,126 | $(1,613) | | **Total operating expenses** | **$43,231** | **$43,193** | **$38** | - As of March 31, 2023, the company held **$202.6 million** in cash, cash equivalents, and short-term investments, which management believes is sufficient to fund operations and capital expenditures for at least the next twelve months[94](index=94&type=chunk)[115](index=115&type=chunk) - Net cash used in operating activities decreased to **$32.1 million** in Q1 2023 from **$46.5 million** in Q1 2022, primarily due to the timing of changes in net operating assets and liabilities[123](index=123&type=chunk)[124](index=124&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=23&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the company is not required to provide disclosures for this item - As a smaller reporting company, AlloVir is not required to disclose quantitative and qualitative information about market risk[134](index=134&type=chunk) [Item 4. Controls and Procedures](index=23&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2023, with no material changes to internal control over financial reporting - The company's management, including the CEO and CFO, concluded that disclosure controls and procedures were effective at the reasonable assurance level as of March 31, 2023[136](index=136&type=chunk) - No material changes in the company's internal control over financial reporting occurred during the quarter[137](index=137&type=chunk) [PART II. OTHER INFORMATION](index=25&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=25&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - As of the reporting date, the company is not a party to any material arbitration or legal proceedings[141](index=141&type=chunk) [Item 1A. Risk Factors](index=25&type=section&id=Item%201A.%20Risk%20Factors) This section outlines key risks, including dependence on posoleucel's success, high development costs, need for additional funding, and intense competition - The company's business is highly dependent on its lead product candidate, posoleucel, and its ability to complete clinical testing and obtain regulatory approval[7](index=7&type=chunk)[179](index=179&type=chunk) - As a late clinical-stage entity, the company has incurred **net losses since inception**, with an **accumulated deficit of $507.0 million** as of March 31, 2023, and anticipates significant future losses[7](index=7&type=chunk)[216](index=216&type=chunk) - Substantial additional funding is required, and an inability to raise capital could force delays, reductions, or elimination of development programs or commercialization efforts[8](index=8&type=chunk)[220](index=220&type=chunk) - The company faces substantial competition from other pharmaceutical and biotechnology companies, which could significantly impact its commercial opportunities if competitors develop more successful products[10](index=10&type=chunk)[163](index=163&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=66&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities during the period - There were no unregistered sales of equity securities during the quarter[280](index=280&type=chunk) [Item 3. Defaults Upon Senior Securities](index=66&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - There were no defaults upon senior securities[280](index=280&type=chunk) [Item 4. Mine Safety Disclosures](index=66&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - This item is not applicable[280](index=280&type=chunk) [Item 5. Other Information](index=66&type=section&id=Item%205.%20Other%20Information) The company reports no other information for this period - There is no other information to report[280](index=280&type=chunk) [Item 6. Exhibits](index=67&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with Form 10-Q, including Sarbanes-Oxley certifications and Inline XBRL data files - Exhibits include certifications from the Principal Executive Officer and Principal Financial Officer pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002[285](index=285&type=chunk) - The report incorporates various Inline XBRL documents (Instance, Schema, Calculation, Definition, Label, Presentation) for financial data tagging[281](index=281&type=chunk)[282](index=282&type=chunk)[283](index=283&type=chunk)

Allogeneic, Off-the-Shelf, Virus-Specific T Cell Therapies in Late-Stage Development February 2023 ...

Product Development - The company is developing three innovative allogeneic virus-specific T cell (VST) therapy candidates targeting 11 different viruses, with the lead product posoleucel aimed at significantly improving outcomes for transplant patients [500]. - Posoleucel is currently being studied in three ongoing Phase 3 trials, with expected completion of enrollment by the end of 2023 and potential data readouts in 2024 [501]. - ALVR106 and ALVR107 are additional investigational VST therapies in development, targeting respiratory diseases and hepatitis B, respectively [502]. - The company has faced disruptions in clinical trials and operations due to the ongoing COVID-19 pandemic, impacting timelines and patient enrollment [511]. - The company expects to incur significant expenses and operating losses as it advances product candidates through clinical development and seeks regulatory approval [537]. Financial Performance - The company reported net losses of $168.7 million and $172.0 million for the years ended December 31, 2022 and 2021, respectively, with an accumulated deficit of $465.8 million as of December 31, 2022 [506]. - The net loss for the year ended December 31, 2022, was $168.7 million, an improvement from a net loss of $171.9 million in 2021 [527]. - Cash, cash equivalents, and short-term investments totaled $233.8 million as of December 31, 2022, expected to fund operations for at least twelve months [509]. - Net cash used in operating activities was $142.1 million for the year ended December 31, 2022, compared to $106.3 million in 2021 [543]. - Net cash provided by financing activities was $127.0 million for the year ended December 31, 2022, primarily from the issuance of common stock [546]. Expenses - The company has incurred significant operating losses primarily due to research and development activities and general administrative costs, with expectations of continued increasing expenses [507]. - Research and development expenses were $118.9 million for the year ended December 31, 2022, a decrease of $1.9 million from $120.7 million in 2021 [530]. - General and administrative expenses increased to $52.3 million in 2022 from $49.1 million in 2021, reflecting a $3.2 million increase [531]. Capital and Financing - The company has not generated any revenue from product sales and relies on capital raising through equity and debt financings to support operations [503]. - The company has received net cash proceeds of approximately $156.3 million from preferred stock sales and $292.0 million from common stock in its IPO [534]. - The relationship with ElevateBio includes shared management and support for drug development and manufacturing services, enhancing the company's operational capabilities [513]. Accounting and Compliance - The company utilizes U.S. GAAP for its consolidated financial statements, requiring estimates and judgments that may affect reported amounts of assets and liabilities [552]. - Stock-based compensation expense is recognized based on the grant date fair value, with a graded-vesting basis for performance conditions [554]. - The fair value of stock options is estimated using the Black-Scholes option-pricing model, considering factors such as expected volatility and risk-free interest rates [556]. - The company is classified as an "emerging growth company" under the JOBS Act, allowing it to delay compliance with certain accounting standards [562]. - The company will remain an emerging growth company until it meets specific revenue or market value thresholds, including total annual gross revenues of at least $1.0 billion [566]. - The company is also classified as a "smaller reporting company," with market value held by non-affiliates less than $700 million and annual revenue below $100 million [567]. - Recent accounting pronouncements that may impact financial position and results of operations are disclosed in the consolidated financial statements [568]. - As a smaller reporting company, the company is not required to disclose quantitative and qualitative disclosures about market risk [570].

Allogeneic, Off-the-Shelf, Virus-Specific T Cell Therapies in Late-Stage Development January 2023 ...